New Approach Methodologies (NAM’s)

What are New Approach Methodologies (NAM’s)?

New Approach Methodologies (NAM’s) are scientifically advanced, non-animal approaches that provide human-relevant insights in drug development, toxicology, and disease modeling. NAM’s include human cell-based assays, organ-on-chip systems, and in-silico computational models designed to reduce reliance on animal testing while improving the accuracy and translatability of research findings. NAM’s are recognized by the FDA and NIH as essential tools for modern drug development. U.S. laws such as FDAMA 2.0 (2022) and FDAMA 3.0 (2025) explicitly encourage the use of NAM’s, removing mandatory animal testing requirements and promoting regulatory adoption of human-relevant methods.

Why NAM’s Matter in Drug Development

Traditional animal models often fail to predict human responses accurately. This can lead to costly late-stage failures in clinical trials and unnecessary use of animals in research. NAM’s address these limitations by providing:

Human-relevant biology: Experimental systems based on human cells and tissue
Predictive power: Mechanistic and functional data that better forecast clinical outcomes
Efficiency and cost reduction: Faster, more targeted research with reduced resource consumption
Regulatory alignment: FDA encourages and expects NAM’s for pre-clinical, biomarker, and translational studies

In short, NAMs help pharmaceutical and biotech companies make more informed decisions earlier in the drug development pipeline while reducing reliance on animal testing.

How the Xsphera Platform Aligns With NAM Principles

The Xsphera platform is designed to meet the highest standards of a NAM, offering a human tissue-based, ex vivo system that preserves the complexity of the tumor microenvironment. Key features include:

Human-Centric Biology

Xsphera leverages fresh human tissue to maintain critical immune and stromal interactions. Unlike traditional animal models, this ensures experimental results are directly relevant to human biology, enhancing translational predictivity.

High-Content, Mechanistic Data

Our platform integrates multi-omic analyses and AI-driven analytics to generate detailed mechanistic insights. This capability provides far more actionable data than standard animal endpoints, enabling researchers to make better-informed decisions.

Regulatory Relevance

The Xsphera system produces high-quality human data that can support discussions with regulatory authorities, including pre-IND interactions. By generating reproducible, human-relevant results, Xsphera aligns with the objectives of emerging regulatory frameworks that emphasize NAMs and alternatives to animal testing.

Fits NAM Categories

Classified as an ex vivo and microphysiological system (MPS), Xsphera fits squarely within the recognized NAM categories. It offers a robust, scalable, and ethically responsible alternative to animal studies while meeting scientific and regulatory expectations.

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